FDA applicant

Harmac Medical Products, Inc.

Buffalo, NY8 decisions1995–20020 recalls

FDA records 8 decisions for Harmac Medical Products, Inc. (Buffalo, NY) from 1995 to 2002: 8 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and LDF (Electrode, Pacemaker, Temporary). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Harmac Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Harmac Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Harmac Medical Products, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Harmac Medical Products, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Harmac”

FDA records each applicant name separately; these may or may not be the same firm.

Harmac Medical Specialties, Inc. 1

Harmac Medical Products, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Harmac”